Implementing a Patient-centred and Evidence-based Intervention to Reduce BEnzodiazepine and Sedative-hypnotic Use to Improve Patient SAFEty and Quality of Care (BE-SAFE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 470
- 试验地点
- 14
- 主要终点
- BSH discontinuation
研究概览
简要总结
Among older adults (≥65 years), use of sleeping pills, such as benzodiazepines and other sedative-hypnotics, to treat sleep problems is common. While sleeping pills are effective in the first few weeks of use, their effect diminishes significantly after that. Especially older adults are susceptible to significant adverse effects of sleep pills, yet stopping sleeping pills remains challenging. BE-SAFE aims to conduct a randomised study testing a patient-centred intervention to reduce sleeping pill use and to improve patient safety and quality of care focusing on implementation aspects. The intervention addresses knowledge and practice gaps related to discontinuation of sleeping pills in older adults with sleep problems.
详细描述
Background:
Use of Benzodiazepine and Sedative Hypnotics (BSHs) is one of the three overuse practices measured by the OECD. BSH use has been reported to be as high as 15-30% in older adults with 87% taking BSHs for sleep problems. Use of BSHs is associated with significant adverse effects such as falls, fractures, hospitalisations, impaired functioning, delirium, dementia and mortality and therefore threatens patient safety. This applies especially to older adults as they are more susceptible to adverse effects due to changes in pharmacokinetics and pharmacodynamics associated with age and to the frequent presence of polypharmacy and comorbidities.
Design:
Multicenter, superiority (first co-primary endpoint) and non-inferiority (second co-primary endpoint) cluster randomised controlled trial (RCT) conducted in six countries across Europe (Belgium, Greece Norway, Poland, Spain, and Switzerland). Participating physicians will be randomly assigned in a 1:1 ratio in clusters to either the intervention group (with training and additional material to overcome sleeping problems and to help participants discontinue BSH) or the control group (treatment according to standard of care without training or additional material). Eligible patients will be enrolled with their treating physician defined as the cluster. Outcome assessment will be blinded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Outcome assessment is performed by research team blinded to the allocated intervention.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥65 years old
- •BSH (ATC codes N05BA, N05CF, N05CD, and N03AE01) use on average ≥3 times a week during the last 3 months prior to providing informed consent, as self-reported by the patient or by the informal carer
- •Taking BSH for sleep problems, as self-reported by the patient or by the informal carer
排除标准
- •Indication for BSH appropriate or withdrawal dangerous, based on available documents (diagnosis list) or General Practitioner (GP) information:
- •Current use of BSH for alcohol withdrawal
- •BSH use in the context of addiction
- •Rapid Eye Movement (REM) sleep Behaviour Disorders
- •Active diagnosis of severe non-REM-related parasomnias with risk of self-damage or giving harm to others or with high frequency or social embarrassment
- •Epilepsy (all forms, because of risk of seizures by sleep deprivation)
- •Current active diagnosis of severe general or specific anxiety disorder (including obsessive compulsive disorder, social phobia, post-traumatic stress disorder, panic disorder with or without agoraphobia)
- •Current active diagnosis of psychotic disorder with or without antipsychotic medication
- •Current active diagnosis of severe depression with or without major anxiety symptoms
- •Current active diagnosis of bipolar disorder with or without major anxiety symptoms
- •Acute suicidal ideation
- •Current formal active tapering process of BSHs supported by a physician
- •Planned admission to palliative care within 24 hours of inclusion or estimated life-expectancy of less than 12 months i.e., patient is in a state or has a diagnosis where the cluster physician would not be surprised if patient dies within the next months (this criterion is relatively vague and subjective but because there is no validated prognostic score, it is justified)
- •Inability to provide informed consent (e.g., because of cognitive impairment), except if a proxy can provide consent, be actively involved in the study, and patient shows no sign of disagreement
研究组 & 干预措施
Physician and patient intervention
Patients in the intervention group will be treated by physicians, who received informative and educative materials (including videos) and training, including guidelines and implementation recommendations on how to deprescribe, on shared-decision making with patients, on how to manage sleep problems using alternative methods other than BSH. Patients receive brochures and access to videos. Communication forms are implemented to ensure continuity of care.
干预措施: Specific tapering plan for sleep medication, educational and cognitive behavioural therapy elements (Other)
Control/Usual care
Participants in the control group receive treatment according to standard care of the prescribing physician, who did not receive any training or additional material.
结局指标
主要结局
BSH discontinuation
时间窗: 12 months after enrollment
Number of patients with BSH discontinuation according to self-/informal carer-disclosure. Discontinuation is defined as the intake of a maximum of one tablet within the previous 14 days.
Quality of sleep
时间窗: 12 months after enrollment
Quality of sleep measured by the Insomnia Severity Index (ISI). The questionnaire consists of 7 questions, answers range from 0-4 points, which are added up to get a total score. The higher the total score, the more severe level of insomnia.
次要结局
- Use of a substitute medication for sleep(2 months, 6 months, and 12 months after enrollment)
- BSH discontinuation discussion with HCP(1 month, 2 months, and 6 months after enrollment)
- Benzodiazepines (BSH) discontinuation or dose reduction(2 months and 6 months after enrollment)
- BSH adverse events(12 months after enrollment)
- Quality of sleep(2 months and 6 months after enrollment)
- BSH standardized daily dose intake(2 months, 6 months, and 12 months after enrollment)
- Health-related quality of life(2 months, 6 months, and 12 months after enrollment)
- Withdrawal symptoms from BSH discontinuation(2 months and 6 months after enrollment)